MedTrace Logo

Bioequivalence of Two Different Drug Product Batches of Dabigatran Etexilate Following Oral Administration in Healthy Male and Female Volunteers

NCT02171013 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2014-06-23

No results posted yet for this study

Summary

To establish the bioequivalence of two drug product batches of dabigatran etexilate, one batch containing only polymorph I vs. the other batch containing 17% of dabigatran etexilate polymorph II in addition to polymorph I

Conditions

  • Healthy

Interventions

DRUG

Dabigatran polymorph I (≈ 83%) and polymorph II (≈17%)

DRUG

Dabigatran polymorph I

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2006-07-31

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02171013 on ClinicalTrials.gov